What are the recommended dosing regimens for fexuprazan in the treatment of gastro‑oesophageal reflux disease, erosive oesophagitis, maintenance therapy, acute or chronic gastritis, and in patients with renal impairment?

Fexuprazan Dosing Recommendations

For erosive esophagitis and GERD, use fexuprazan 40 mg once daily for 4-8 weeks; for acute or chronic gastritis, use either 20 mg once daily or 10 mg twice daily for 2 weeks; in patients with kidney disease, consult a physician for dose adjustment. 1

Standard Dosing by Indication

Erosive Esophagitis (EE)

• Acute treatment: Fexuprazan 40 mg once daily for 4-8 weeks 2, 3
• This dosing demonstrated non-inferior efficacy to esomeprazole 40 mg, with healing rates of 97-99% at 8 weeks 2, 3
• Most patients achieve healing by 4 weeks (88-90% healing rate), but continue to 8 weeks if needed 3

Acute or Chronic Gastritis

• Option 1: Fexuprazan 20 mg once daily for 2 weeks 4
• Option 2: Fexuprazan 10 mg twice daily for 2 weeks 4
• Both regimens showed superior erosion improvement rates (58-66%) compared to placebo (41%) 4
• The twice-daily 10 mg regimen showed slightly higher efficacy (66% vs 58%) but either is acceptable 4

GERD-Related Symptoms (Including Chronic Cough)

• Fexuprazan 40 mg once daily for 8 weeks 5
• Comparable efficacy to esomeprazole for symptom relief and quality of life improvement 5

Age and Population Considerations

Adults and Children ≥12 Years

• Standard adult dosing applies 1
• Maximum: Do not exceed 1 tablet in 24 hours 1

Adults ≥65 Years

• Consult a physician before use 1
• No specific dose reduction mentioned in available evidence, but clinical judgment warranted

Children <12 Years

• Do not use - not approved for this age group 1

Special Populations

Renal Impairment

• Critical: Patients with kidney disease must consult a physician for dose determination 1
• The FDA label explicitly states physicians should determine if a different dose is needed 1
• No specific renal dosing guidelines provided in current evidence

Hepatic Impairment

• No specific dosing adjustments mentioned in available evidence

Administration Guidelines

Timing and Food

• Take once daily with water 1
• Key advantage: Unlike PPIs, fexuprazan does not require timing relative to meals for optimal efficacy 6
• This represents a practical advantage over PPIs that require pre-meal dosing

Drug Interactions to Avoid

• Do not take simultaneously with aluminum or magnesium antacids 1
• Do not take with fruit juices 1
• These can interfere with absorption

Maintenance Therapy Considerations

While specific maintenance dosing for fexuprazan is not detailed in the provided evidence, the general GERD management principles apply:

• After successful healing of EE, consider maintenance therapy for severe GERD 7
• Attempt to taper to the lowest effective dose in responders 7
• For patients without erosive disease who respond well, consider on-demand therapy rather than continuous treatment 7

Safety Profile

• Well-tolerated with adverse event rates (19.4%) comparable to esomeprazole (19.6%) 2
• Most common side effects: mild gastrointestinal symptoms 2, 3
• Serum gastrin elevation similar to PPIs, with no concerning safety signals 3

Clinical Pearls

Advantages over PPIs:

• Rapid onset of action (no acid activation required) 6
• Durable acid suppression over 24 hours 6
• No CYP2C19 metabolism variability 6
• Convenient once-daily dosing without meal timing requirements 6

When to stop and reassess:

• If allergic reaction occurs, discontinue immediately and seek medical help 1
• Evaluate appropriateness of continued therapy at 12 months if GERD remains unproven 7